Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT00617305
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2008-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C467894', 'term': 'ambrisentan'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ellen.Shen@gilead.com', 'phone': '+1 (650) 522-5278', 'title': 'Ellen Shen, PhD, Senior Manager, Regulatory Affairs', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and serious adverse events (SAEs) were reported through Week 48.', 'description': 'AEs/SAEs were analyzed for patients who: received ambrisentan but not placebo ("Ambrisentan Only"); received ambrisentan and did or did not receive placebo ("Any Ambrisentan"); received placebo and did or did not receive ambrisentan ("Any Placebo"). Safety analysis was not done for the "Ambrisentan/Placebo" or "Placebo Only" groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)', 'otherNumAtRisk': 33, 'otherNumAffected': 32, 'seriousNumAtRisk': 33, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i', 'otherNumAtRisk': 37, 'otherNumAffected': 36, 'seriousNumAtRisk': 37, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Protein total increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urine leukocyte esterase positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal haemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophageal splasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '761.2', 'spread': '306.57', 'groupId': 'OG000'}, {'value': '731.6', 'spread': '278.02', 'groupId': 'OG001'}, {'value': '758.0', 'spread': '300.12', 'groupId': 'OG003'}, {'value': '703.6', 'spread': '248.73', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '518.8', 'spread': '196.35', 'groupId': 'OG000'}, {'value': '439.8', 'spread': '130.34', 'groupId': 'OG001'}, {'value': '509.8', 'spread': '190.18', 'groupId': 'OG003'}, {'value': '439.8', 'spread': '130.34', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-248.93', 'ciLowerLimit': '-337.7', 'ciUpperLimit': '-160.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '241.978', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-291.80', 'ciLowerLimit': '-619.4', 'ciUpperLimit': '35.78', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '205.864', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-253.83', 'ciLowerLimit': '-334.8', 'ciUpperLimit': '-172.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '235.787', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-291.80', 'ciLowerLimit': '-619.4', 'ciUpperLimit': '35.78', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '205.864', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm\\^5) indicates improvement for this patient population.', 'unitOfMeasure': 'dynes sec/cm^5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with measurements at Baseline and Week 24 were evaluated'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '49.9', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '12.50', 'groupId': 'OG001'}, {'value': '50.4', 'spread': '9.98', 'groupId': 'OG003'}, {'value': '52.8', 'spread': '11.48', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '44.4', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '38.8', 'spread': '9.60', 'groupId': 'OG001'}, {'value': '43.8', 'spread': '10.83', 'groupId': 'OG003'}, {'value': '38.8', 'spread': '9.60', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.38', 'ciLowerLimit': '-8.29', 'ciUpperLimit': '-2.46', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.954', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.75', 'ciLowerLimit': '-29.64', 'ciUpperLimit': '-1.86', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.732', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.56', 'ciLowerLimit': '-9.51', 'ciUpperLimit': '-3.61', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.589', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.75', 'ciLowerLimit': '-29.64', 'ciUpperLimit': '-1.86', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.732', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with measurements at Baseline and Week 24 were evaluated'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.5', 'spread': '4.82', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '4.64', 'groupId': 'OG003'}, {'value': '11.1', 'spread': '2.97', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '8.4', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '4.66', 'groupId': 'OG003'}, {'value': '6.3', 'spread': '1.71', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '1.56', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.442', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.00', 'ciLowerLimit': '-10.50', 'ciUpperLimit': '2.50', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.082', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '1.04', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.527', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.00', 'ciLowerLimit': '-10.50', 'ciUpperLimit': '2.50', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.082', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with measurements at Baseline and Week 24 were evaluated'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cardiac Output (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '1.17', 'groupId': 'OG003'}, {'value': '4.8', 'spread': '0.71', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '1.24', 'groupId': 'OG003'}, {'value': '5.2', 'spread': '1.22', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.053', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '1.42', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.685', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.15', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.021', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '1.42', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.685', 'groupDescription': 'Mean change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'This secondary hemodynamic outcome is supportive of the primary outcome. An increase in measurement value (L/min) indicates improvement for this patient population.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with measurements at Baseline and Week 24 were evaluated'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '361.9', 'spread': '98.74', 'groupId': 'OG000'}, {'value': '433.3', 'spread': '80.77', 'groupId': 'OG001'}, {'value': '335.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '369.6', 'spread': '98.56', 'groupId': 'OG003'}, {'value': '413.6', 'spread': '82.61', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '376.5', 'spread': '106.08', 'groupId': 'OG000'}, {'value': '441.0', 'spread': '83.88', 'groupId': 'OG001'}, {'value': '442.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '383.7', 'spread': '104.85', 'groupId': 'OG003'}, {'value': '441.2', 'spread': '72.65', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '377.9', 'spread': '109.61', 'groupId': 'OG000'}, {'value': '435.8', 'spread': '134.61', 'groupId': 'OG001'}, {'value': '422.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '384.3', 'spread': '111.96', 'groupId': 'OG003'}, {'value': '433.0', 'spread': '116.74', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '382.4', 'spread': '104.96', 'groupId': 'OG000'}, {'value': '423.8', 'spread': '110.05', 'groupId': 'OG001'}, {'value': '422.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '387.0', 'spread': '104.73', 'groupId': 'OG003'}, {'value': '423.4', 'spread': '95.31', 'groupId': 'OG004'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '366.5', 'spread': '127.62', 'groupId': 'OG000'}, {'value': '399.3', 'spread': '152.93', 'groupId': 'OG001'}, {'value': '402.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '370.2', 'spread': '128.61', 'groupId': 'OG003'}, {'value': '399.8', 'spread': '132.45', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '378.9', 'spread': '124.18', 'groupId': 'OG000'}, {'value': '383.5', 'spread': '192.47', 'groupId': 'OG001'}, {'value': '402.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '379.4', 'spread': '129.75', 'groupId': 'OG003'}, {'value': '387.2', 'spread': '166.89', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '28.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '44.84', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '-26.0', 'ciUpperLimit': '41.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '21.19', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '107.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '26.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '42.68', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.6', 'ciLowerLimit': '-32.0', 'ciUpperLimit': '87.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '48.03', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '28.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '41.46', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-91.5', 'ciUpperLimit': '96.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '59.09', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '87.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.4', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '26.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '42.83', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.4', 'ciLowerLimit': '-59.6', 'ciUpperLimit': '98.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '63.61', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '0.5', 'ciUpperLimit': '35.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '48.67', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-56.5', 'ciUpperLimit': '37.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.56', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '87.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '31.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '47.44', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '-52.5', 'ciUpperLimit': '72.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '50.18', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-25.6', 'ciUpperLimit': '30.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '77.24', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.0', 'ciLowerLimit': '-182.2', 'ciUpperLimit': '114.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '93.16', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '67.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-28.4', 'ciUpperLimit': '24.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '78.50', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.8', 'ciLowerLimit': '-128.6', 'ciUpperLimit': '101.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '92.46', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '-15.0', 'ciUpperLimit': '44.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '82.07', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.8', 'ciLowerLimit': '-251.4', 'ciUpperLimit': '151.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '126.75', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '67.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '-22.4', 'ciUpperLimit': '37.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '88.11', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.4', 'ciLowerLimit': '-177.3', 'ciUpperLimit': '124.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '121.55', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. An increase in measurement value (meters walked) indicates improvement for this patient population.', 'unitOfMeasure': 'meters walked', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled Population'}, {'type': 'SECONDARY', 'title': 'Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '2.03', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '1.14', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '1.71', 'groupId': 'OG003'}, {'value': '3.0', 'spread': '2.00', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '2.02', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '2.49', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.91', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '1.24', 'groupId': 'OG004'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '2.29', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '2.30', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '4.04', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '2.49', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '3.51', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.50', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '3.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.50', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-1.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.54', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.52', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.45', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '5.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.38', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '0.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.67', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '3.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.17', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.81', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.75', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '0.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.72', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.71', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.79', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '4.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.00', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '0.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.85', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '3.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.79', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.12', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '6.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.46', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '0.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.30', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '4.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.03', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. The dyspnea index measures the degree of breathlessness after completion of the 6MWT using a scale of 0 to 10, with 0 indicating no breathlessness and 10 indicating maximum breathlessness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '5.44', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '6.12', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '4.71', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.8', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '3.11', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '5.32', 'groupId': 'OG003'}, {'value': '4.8', 'spread': '3.11', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '7.2', 'spread': '5.82', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '5.69', 'groupId': 'OG003'}, {'value': '2.8', 'spread': '2.59', 'groupId': 'OG004'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '7.7', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.70', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '5.98', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '3.21', 'groupId': 'OG004'}]}]}, {'title': 'Week48', 'categories': [{'measurements': [{'value': '7.6', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '3.50', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '7.1', 'spread': '6.63', 'groupId': 'OG003'}, {'value': '3.6', 'spread': '3.05', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.98', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '9.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.86', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-2.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.09', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '6.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.45', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.00', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '5.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.03', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-2.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.84', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '3.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.51', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.20', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '6.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.65', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-1.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.07', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '4.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.02', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '2.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.33', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '10.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.86', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-1.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.28', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '6.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.94', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 12, 36, and 48 were also evaluated. Lower scores and decreases from baseline represent improved functioning and QOL. The CAMPHOR survey was not assessed at Week 4. The total CAMPHOR score scale ranges from 0 (good) to 25 (poor). A reduction in score over time represents improvement in this patient population.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Week 4 - Improvement', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 - No Change', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 - Deterioration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 - Missing Data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 - Improvement', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 - No Change', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 - Deterioration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 - Missing Data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 - Improvement', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 - No Change', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 - Deterioration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 - Missing Data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 - Improvement', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 - No Change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 - Deterioration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 - Missing Data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 - Improvement', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 - No Change', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 - Deterioration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 - Missing Data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. WHO categories are 1 to 4 with the worst category being 4. Improvement is represented by a change in category to a lower number (for example, change from category 3 to 2), and deterioration is represented by a change in category to a higher number (for example, change from category 2 to 4). No change is represented by no change in category (for example, category 2 which remains 2).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)'}, {'id': 'OG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)'}, {'id': 'OG003', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}, {'id': 'OG004', 'title': 'Any Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.10', 'groupId': 'OG000', 'lowerLimit': '19.62', 'upperLimit': '43.89'}, {'value': '6.7', 'spread': '1.02', 'groupId': 'OG001', 'lowerLimit': '-940.3', 'upperLimit': '93.22'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '1.10', 'groupId': 'OG003', 'lowerLimit': '19.30', 'upperLimit': '42.62'}, {'value': '6.7', 'spread': '1.02', 'groupId': 'OG004', 'lowerLimit': '-940.3', 'upperLimit': '93.22'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '1.80', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '1.05', 'groupId': 'OG003'}, {'value': '6.7', 'spread': '1.46', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '5.8', 'spread': '0.99', 'groupId': 'OG003'}, {'value': '6.8', 'spread': '0.80', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '1.02', 'groupId': 'OG003'}, {'value': '6.4', 'spread': '1.12', 'groupId': 'OG004'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '1.14', 'groupId': 'OG003'}, {'value': '6.3', 'spread': '1.08', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '1.14', 'groupId': 'OG003'}, {'value': '6.7', 'spread': '1.01', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.50', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.28', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.49', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.28', 'groupDescription': 'Mean change from Baseline to Week 4 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.63', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.07', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.64', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.07', 'groupDescription': 'Mean change from Baseline to Week 12 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.83', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.34', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.81', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.34', 'groupDescription': 'Mean change from Baseline to Week 24 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.92', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.90', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.91', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.90', 'groupDescription': 'Mean change from Baseline to Week 36 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.91', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.77', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.88', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.77', 'groupDescription': 'Mean change from Baseline to Week 48 (LOCF)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean percent change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. A decrease in log-transformed measurement value (pg/mL) indicates improvement for this patient population.', 'unitOfMeasure': 'pg/mL (log-transformed)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient (Any Placebo) was not evaluated for NT-proBNP. One patient (Placebo Only) had no baseline measurement, so no statistical analyses for change from baseline are given for the placebo only group (patient was only subject in this group).'}, {'type': 'SECONDARY', 'title': 'Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}], 'classes': [{'title': 'At Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 20', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.1'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.2'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.1'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.2'}]}]}, {'title': 'At Week 28', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '14.7'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '13.1'}]}]}, {'title': 'At Week 32', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '29.1'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '25.9'}]}]}, {'title': 'At Week 36', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '29.1'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '25.9'}]}]}, {'title': 'At Week 40', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '34.0'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '30.1'}]}]}, {'title': 'At Week 44', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '34.0'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '30.1'}]}]}, {'title': 'At Week 48', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '34.0'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '30.1'}]}]}, {'title': 'After Week 48', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '34.0'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '30.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 48+', 'description': 'The time to clinical worsening was defined as the time from enrollment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, or initiation of chronic parenteral prostanoid therapy. Results are presented as the Kaplan-Meier estimate (% probability) of having clinical worsening after a given time.', 'unitOfMeasure': 'Probability of clinical worsening (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Time to Clinical Worsening'}, {'type': 'SECONDARY', 'title': 'Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)'}, {'id': 'OG001', 'title': 'Any Ambrisentan', 'description': 'Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)'}], 'classes': [{'title': 'At Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 32', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 36', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'At Week 40', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.8'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.4'}]}]}, {'title': 'At Week 44', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.8'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.4'}]}]}, {'title': 'At Week 48', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.8'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.4'}]}]}, {'title': 'After Week 48', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.8'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 48+', 'description': 'Overall survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of death after a given time.', 'unitOfMeasure': 'Probability of death occurring (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Overall Survival'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)'}, {'id': 'FG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i'}, {'id': 'FG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Completed 24-week Primary Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled in 16 study sites in the US. The first patient was screened on 09 April 2008, and the last patient was enrolled on 28 July 2010. The last patient observation was on 25 July 2011. Originally a double-blind, placebo-controlled study, it was changed to open label on 12 June 2009 due to slow enrollment.', 'preAssignmentDetails': '65 patients were screened; 8 were randomized (3 to ambrisentan and 5 to placebo) prior to study conversion to open label. The remaining patients were assigned to ambrisentan treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ambrisentan Only', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)'}, {'id': 'BG001', 'title': 'Placebo/Ambrisentan', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i'}, {'id': 'BG002', 'title': 'Placebo Only', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '13.72', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '14.89', 'groupId': 'BG001'}, {'value': '49.0', 'spread': '0', 'groupId': 'BG002'}, {'value': '47.8', 'spread': '13.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-22', 'studyFirstSubmitDate': '2008-02-06', 'resultsFirstSubmitDate': '2012-05-11', 'studyFirstSubmitQcDate': '2008-02-15', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-22', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline to Week 24', 'description': 'The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm\\^5) indicates improvement for this patient population.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)', 'timeFrame': 'Baseline to Week 24', 'description': 'This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.'}, {'measure': 'Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)', 'timeFrame': 'Baseline to Week 24', 'description': 'This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.'}, {'measure': 'Change From Baseline in Cardiac Output (LOCF)', 'timeFrame': 'Baseline to Week 24', 'description': 'This secondary hemodynamic outcome is supportive of the primary outcome. An increase in measurement value (L/min) indicates improvement for this patient population.'}, {'measure': 'Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. An increase in measurement value (meters walked) indicates improvement for this patient population.'}, {'measure': 'Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. The dyspnea index measures the degree of breathlessness after completion of the 6MWT using a scale of 0 to 10, with 0 indicating no breathlessness and 10 indicating maximum breathlessness.'}, {'measure': 'Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 12, 36, and 48 were also evaluated. Lower scores and decreases from baseline represent improved functioning and QOL. The CAMPHOR survey was not assessed at Week 4. The total CAMPHOR score scale ranges from 0 (good) to 25 (poor). A reduction in score over time represents improvement in this patient population.'}, {'measure': 'Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. WHO categories are 1 to 4 with the worst category being 4. Improvement is represented by a change in category to a lower number (for example, change from category 3 to 2), and deterioration is represented by a change in category to a higher number (for example, change from category 2 to 4). No change is represented by no change in category (for example, category 2 which remains 2).'}, {'measure': 'Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)', 'timeFrame': 'Baseline to Week 48', 'description': 'The primary analysis of this secondary outcome measure is mean percent change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. A decrease in log-transformed measurement value (pg/mL) indicates improvement for this patient population.'}, {'measure': 'Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48', 'timeFrame': 'Baseline to Week 48+', 'description': 'The time to clinical worsening was defined as the time from enrollment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, or initiation of chronic parenteral prostanoid therapy. Results are presented as the Kaplan-Meier estimate (% probability) of having clinical worsening after a given time.'}, {'measure': 'Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48', 'timeFrame': 'Baseline to Week 48+', 'description': 'Overall survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of death after a given time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ambrisentan', 'PAH', 'combination therapy', 'phosphodiesterase type-5 inhibitor (PDE-5i)', 'cardiovascular', 'endothelin receptor antagonist', 'ERA'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.letairis.com/patients/default.asp', 'label': 'Click here for more information about ambrisentan'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PDE-5i monotherapy.\n\nThe study was originally designed as a 2-arm, double-blind, randomized study in which patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to single-arm, open-label treatment, and all patients remaining in the placebo arm were switched to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received open-label ambrisentan.', 'detailedDescription': 'The primary objective of this study is to evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PDE-5i monotherapy.\n\nThe secondary objectives of this study are to evaluate the change from baseline in other clinical measures of PAH following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy.\n\nThe safety and tolerability of ambrisentan/PDE-5i combination therapy will be evaluated throughout the study. In addition, long-term efficacy will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Selected Inclusion Criteria\n\n* Must be between 16 and 75 years of age;\n* Must weigh at least 40 kg;\n* Have a current diagnosis of idiopathic PAH, familial PAH, or PAH that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or human immunodeficiency virus (HIV);\n* Have WHO functional class III symptoms;\n* Be receiving sildenafil or tadalafil monotherapy for the treatment of PAH for at least the past 12 weeks and at a stable dose for at least 8 consecutive weeks;\n* Meet all of the following hemodynamic criteria by means of a right heart catheterization: mPAP of at least 25 mmHg; PVR of at least 400 dyne\\*sec/cm5; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of not more than 15 mmHg;\n* Meet all of the following pulmonary function test criteria no more than 12 weeks before the screening visit: total lung capacity at least 60% of predicted normal and forced expiratory volume in 1 second of at least 65% of predicted normal;\n* Able to walk at least 150 meters during the screening 6-minute walk test (6MWT);\n* If receiving calcium channel blockers or 5-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (i.e., statins) must be on stable therapy for at least 4 weeks;\n* If diagnosed with HIV, must have stable disease status.\n\nSelected Exclusion Criteria:\n\n* Have a current pulmonary hypertension diagnosis other than idiopathic PAH, familial PAH, or PAH that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or HIV;\n* Have left ventricular ejection fraction (LVEF) ≤40% or clinically significant ischemic, valvular, or constrictive heart disease;\n* Have received chronic prostanoid or endothelin receptor antagonist (ERA) therapy (eg, bosentan, sitaxsentan) within the past 12 weeks;\n* Have discontinued ERA treatment for any adverse reaction other than those associated with liver function test abnormalities;\n* Have received IV inotropes within 2 weeks;\n* Have a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is greater than 2.0x the upper limit of normal.'}, 'identificationModule': {'nctId': 'NCT00617305', 'acronym': 'ATHENA-1', 'briefTitle': 'Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 Inhibitor', 'orgStudyIdInfo': {'id': 'GS-US-300-0117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ambrisentan', 'description': 'Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i; sildenafil or tadalafil).', 'interventionNames': ['Drug: Ambrisentan', 'Drug: Sildenafil', 'Drug: Tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (sildenafil or tadalafil).', 'interventionNames': ['Drug: Placebo', 'Drug: Sildenafil', 'Drug: Tadalafil']}], 'interventions': [{'name': 'Ambrisentan', 'type': 'DRUG', 'otherNames': ['Letairis'], 'description': 'Ambrisentan was administered orally once daily; dose level was 5 mg for the first 4 weeks, followed by 10 mg for the remainder of the study; ambrisentan was supplied as 5-mg and 10-mg tablets.', 'armGroupLabels': ['Ambrisentan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match ambrisentan was administered orally once daily.', 'armGroupLabels': ['Placebo']}, {'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Revatio', 'Viagra'], 'description': 'Sildenafil was administered at the dose previously established for each subject (20-100 mg) orally three times daily. Sildenafil was supplied as 20-mg tablets, or formulated as sildenafil citrate in 25-, 50-, or 100-mg tablets.', 'armGroupLabels': ['Ambrisentan', 'Placebo']}, {'name': 'Tadalafil', 'type': 'DRUG', 'otherNames': ['Cialis', 'Adcirca'], 'description': 'Tadalafil was administered at the dose previously established for each subject (not to exceed 40 mg per day) orally once daily. Tadalafil was supplied as 20-mg tablets.', 'armGroupLabels': ['Ambrisentan', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pulmonary Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'West Los Angeles Healthcare Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33331', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Heart Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Institute for Medical Research', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'BACH Cardiology', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Cardiology Associates', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Clinical Trial Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Memorial Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}